Development and Validation of a Predictive Score for Surgical Site Infections

NCT05523713 | Completed DMC

• 1 other identifier: 2022-A01012-41
• Study Type: interventional
• Target: 283
• Locations: 1 country
• Sites: 4

Brief Summary

More than 8 millions surgical interventions are carried out each year in France. Postoperative complications, in particular infectious, can occur in 10 to 60% of cases and are the cause of postoperative revision in 30% of cases, an increase in mortality, length of stay, readmissions and lead to significant additional socio-economic costs. Currently, improvements in surgical practices have not reduced the incidence of surgical site complications. In this context, the development of predictive scores for the risk of post-operative complication becomes urgent in order to implement new interventions (pre-habilitation) or to modify surgical decisions (timing, approach) in order to reduce the risk of complications before surgery. Several recent studies highlights the importance of the immune response in postoperative prognosis. In particular, an imbalance between the adaptive and innate response involving MDSCs has been demonstrated in patients with postoperative complications.Thanks to new techniques for analyzing the immune system, in-depth analysis of the immune system before surgery is a very promising approach aimed at identifying predictive biomarkers of postoperative prognosis. Our team has developed and patented a multivariate model integrating mass cytometry data, proteomics and clinical data collected before surgery to accurately predict the occurrence of a surgical site complication (AUC = 0.94, p\<10e-7) in a monocentric cohort of 43 patients to major abdominal surgery (Stanford University). The objective of the present study is to generalize and validate this preoperative predictive score of infectious complications of the surgical site in the 30 days following major digestive surgery on a larger workforce within a multicenter cohort and to validate this score at using a machine learning method.

Conditions

Colon or Colorectal Resection; Partial or Total Gastrectomy; Pancreaticoduodenectomy; Hepatectomy

Outcome Measures

Primary Outcomes (1)

• Performance of the preoperative prediction score for infectious complications of the surgical site.

  Defined as superficial or deep surgical site infection and organ as defined by CDC 2021. The performance of the score will be evaluate based on the F1 score criterion and the AUROC. F1: score ranges from 0 to 1, where 0 is the worst and 1 is the best possible score. AUROC: score ranges from 0.5 to 1 where 1 is the best score and 0.5 means the model is as good as random.

  30 days

Secondary Outcomes (15)

• Performance of the postoperative prediction score for infectious complications of the surgical site.

  30 days

• Performance of the preoperative prediction score for lung infections

  30 days

• Performance of the preoperative prediction score for urinary tract infections

  30 days

• Performance of the pre- and post-operative prediction score for the risk of post-operative septic shock

  30 days

• Performance of the pre- and post-operative prediction score for postoperative cardiovascular complications

  30 days

Other Outcomes (1)

• Performance of the global model

  30 days

Study Arms (1)

Patients with major elective digestive surgery

OTHER

The size of the cohort is 300 patients Population: Patients with major elective digestive surgery (eg, colon or colorectal resection, partial or total gastrectomy, pancreaticoduodenectomy, hepatectomy).

Biological: Peripheral venous blood samples

Interventions

Peripheral venous blood samples BIOLOGICAL

10 ml in a sodium heparin tube and 5 ml in an EDTA tube

Patients with major elective digestive surgery

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients will be included:
• Aged 18 and over
• Having undergone elective major digestive surgery:
• Major surgery defined according to the recent recommendations of the European Surgical Association - PMID: 32172309 by a rate of infectious or cognitive complications between 20 and 30% according to the ACS risk calculator
• Having expressed their non-opposition to participate in the study
• Being affiliated to a French health insurance

You may not qualify if:

• Patients with the following criteria will not be included:
• Aged under 18
• Having an ASA 4 or more, in palliative care
• Having an expected duration of hospitalization \< 24 hours
• Not speaking French, illiterate patient
• Having expressed their opposition to participate in the study
• Current pregnancy or breastfeeding
• Absence of affiliation to social security plan
• Being deprived of liberty or under guardianship

Sponsors & Collaborators

• Hopital Foch: lead
• surge2surgery: collaborator

Study Sites (4)

La pitiè Salpâtrière Hospital

Paris, France

Location

Saint Antoine Hospital

Paris, France

Location

Saint Joseph Hospital

Paris, France

Location

FOCH Hospital

Suresnes, France

Location

Related Publications (5)

• Storesund A, Haugen AS, Hjortas M, Nortvedt MW, Flaatten H, Eide GE, Boermeester MA, Sevdalis N, Softeland E. Accuracy of surgical complication rate estimation using ICD-10 codes. Br J Surg. 2019 Feb;106(3):236-244. doi: 10.1002/bjs.10985. Epub 2018 Sep 18.

  PMID: 30229870 BACKGROUND

• Hawn MT, Vick CC, Richman J, Holman W, Deierhoi RJ, Graham LA, Henderson WG, Itani KM. Surgical site infection prevention: time to move beyond the surgical care improvement program. Ann Surg. 2011 Sep;254(3):494-9; discussion 499-501. doi: 10.1097/SLA.0b013e31822c6929.

  PMID: 21817889 BACKGROUND

• Gaudilliere B, Angst MS, Hotchkiss RS. Deep Immune Profiling in Trauma and Sepsis: Flow Is the Way to Go! Crit Care Med. 2017 Sep;45(9):1577-1578. doi: 10.1097/CCM.0000000000002594. No abstract available.

  PMID: 28816846 BACKGROUND

• Zhu X, Herrera G, Ochoa JB. Immunosupression and infection after major surgery: a nutritional deficiency. Crit Care Clin. 2010 Jul;26(3):491-500, ix. doi: 10.1016/j.ccc.2010.04.004.

  PMID: 20643302 BACKGROUND

• Gaudilliere B, Fragiadakis GK, Bruggner RV, Nicolau M, Finck R, Tingle M, Silva J, Ganio EA, Yeh CG, Maloney WJ, Huddleston JI, Goodman SB, Davis MM, Bendall SC, Fantl WJ, Angst MS, Nolan GP. Clinical recovery from surgery correlates with single-cell immune signatures. Sci Transl Med. 2014 Sep 24;6(255):255ra131. doi: 10.1126/scitranslmed.3009701.

  PMID: 25253674 BACKGROUND

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 5, 2022
• First Posted: August 31, 2022
• Study Start: October 6, 2022
• Primary Completion: November 29, 2023
• Study Completion: January 27, 2025
• Last Updated: March 13, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

FR (4)